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- tdsteele@outlook.com
Nonclinical Safety Solutions (NCSS) provides senior-level nonclinical safety strategy and expert toxicology consulting to support pharmaceutical and biotech programs across the development lifecycle. NCSS focuses on scientific interpretation, regulatory alignment, and defensible decision-making rather than routine execution.
Our services include strategic toxicology planning , IND/CTA submission support , preclinical study strategy and oversight , regulatory strategy and risk assessment , and independent safety evaluations from early discovery through regulatory submission.
Drawing on prior FDA review experience and more than 25 years in industry, NCSS helps development teams navigate complex nonclinical safety requirements with clarity, precision, and confidence—anticipating regulatory expectations and reducing downstream risk. For programs involving complex modalities, see specialized toxicology strategies for oncology, biologics, and advanced modalities .
Precision toxicology guidance to design, evaluate, and strengthen nonclinical safety programs from early development through clinical entry, grounded in scientific interpretation and regulatory alignment.
Independent scientific diligence to identify safety liabilities, evaluate impurity risk, and inform confident, data-driven development and investment decisions.
Strategic study planning and expert scientific oversight to ensure nonclinical programs are well-designed, appropriately scoped, and fully aligned with regulatory expectations.
Proactive regulatory insight to identify risks early, address critical data gaps, and build a defensible nonclinical strategy that supports efficient agency interactions.
Clear, cohesive, regulator-ready nonclinical narratives developed with direct insight into how FDA and global health authorities evaluate safety data.
Integrated interpretation of pharmacology, ADME, and PK/TK data to support exposure-based safety justifications, starting-dose rationale, and clinical translation.
Tailored nonclinical safety strategies addressing the unique challenges of oncology programs, biologics, imaging agents, and other complex therapeutic modalities where standard approaches may not apply.
Nonclinical development programs face increasing regulatory scrutiny. A dedicated toxicology consultant provides senior scientific judgment and regulatory insight to identify risk early and support defensible, regulator-aligned development decisions.
Dr. Thomas D. Steele is a veteran toxicologist with over 25 years of combined industry and FDA experience, specializing in nonclinical safety evaluation and regulatory strategy. He has led toxicology programs across major pharmaceutical organizations and provides senior scientific guidance to help clients design, interpret, and defend their nonclinical development plans.